Seltorexant for Depression

Recruiting at 142 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: SSRIs, SNRIs

Disqualifiers: Severe renal insufficiency, Cardiovascular, Diabetes, Suicidal ideation, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

588 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing seltorexant, a new medication, to help people with depression and sleep problems who haven't improved enough with their current antidepressants. Seltorexant works by blocking a brain receptor to help improve sleep and mood.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it requires participants to continue taking a stable dose of their current SSRI or SNRI antidepressant.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Adults with major depressive disorder and insomnia who haven't improved enough on SSRIs or SNRIs can join. They must have a BMI of 18-40, stable health, no severe mental disorders like bipolar or psychosis, no serious sleep disorders other than insomnia, and not be at high risk for suicide.

Inclusion Criteria

I've tried 1-2 antidepressants for my current depression episode without enough improvement.

I've been taking a specific antidepressant without issues for 6 weeks to 18 months.

Your body mass index (BMI) falls within the range of 18 to 40 kilograms per square meter (kg/m^2).

Exclusion Criteria

I have a significant sleep disorder, but not insomnia.

You have had a serious problem with using drugs or alcohol in the past 6 months.

I do not have severe kidney issues or uncontrolled health problems including diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Double-blind Treatment

Participants receive either seltorexant or placebo as adjunctive therapy to antidepressants

6 weeks

Weekly visits

Open-label Treatment

Eligible participants receive seltorexant daily to assess long-term safety and tolerability

1 year

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Placebo
• Seltorexant

Trial Overview The trial is testing Seltorexant as an add-on to antidepressants against a placebo in people whose depression-related insomnia hasn't improved much with current treatments. It also looks at the long-term safety of Seltorexant.

Participant Groups

Group I: Seltorexant Experimental Treatment 1 Intervention

Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (Up to 1 Year).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires